AstraZeneca
The purpose of this modular, first trial in human study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ascending dose levels (DLs) of AZD4956 monotherapy and in combination with other anti-cancer agents in participants with advanced/metastatic solid tumours with homologous recombination repair (HRR) deficiencies.
The study consists of individual modules each evaluating the safety and tolerability of AZD4956 dosed as monotherapy, or with a specific combination partner. There are following 2 modules - 1. Module 1: AZD4956 monotherapy 2. Module 2: AZD4956 in combination with saruparib Each module may further contain 2 parts- * Part A (dose escalation/dose finding): To determine the safety, tolerability, PK, PD, and preliminary efficacy of AZD4956 as monotherapy or in combination. * Part B (dose expansion): To further evaluate the safety and preliminary efficacy of AZD4956 in combination with other anti…
Core Inclusion Criteria: * Documented locally advanced or metastatic solid tumour malignancy. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to screening and first day of dosing. * Minimum life expectancy ≥ 12 weeks. * Adequate organ and marrow function. * Female participants must not breastfeed and must not donate or retrieve ova for their own use from screening to approximately 6 months after the last dose of study intervention. Module 1 Inclusion Criteria: * Demonstrated evidence of disease progression. * Par…
AZD4956 will be administered orally.
Saruparib will be administered orally.